Effects of a Robot-based Sensorimotor Upper Limb Rehabilitation Paradigm in Chronic Stroke
Starting soon · Not applicable
Conditions studied: Stroke, Healthy Adult
In brief
Sensorimotor function of the upper limb is commonly impaired after stroke, even in the chronic phase (\>6 months post-stroke). Nevertheless, good sensorimotor function is needed for daily life functioning. Sensorimotor function can be divided into three components: exteroception, proprioception and sensory processing. It is important that those three components will each be addressed in the upper limb rehabilitation. Unfortunately, there is still no optimal therapy to address sensory processing. Therefore, the investigators developed an intensive sensorimotor robot-based rehabilitation paradigm (called ROBUST) with focus on sensory processing. As a first step, the investigators did a pilot study (S69003) including 10 persons with chronic stroke to investigate the potential effectiveness and feasibility of this novel rehabilitation. The median change score of motor, sensory and sensorimotor assessments was exceeding the minimal clinical important difference (MCID), and the total amount of therapy was feasible as well. The investigated protocols to measure potential changes in brain function (activity and connectivity) and structure accompanying the novel therapy appeared feasible as well. Based on this first pilot study, the investigators finalized the protocol for this RCT to investigate the effectiveness of the ROBUST intervention.
Key facts
- Study ID
- NCT07547800
- Run by
- KU Leuven
- People needed
- 109
- Starts
- 2026-04-17
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-05-11
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Having musculoskeletal and/or other neurological disorders impacting care or prognosis;
- Having severe communication or cognitive deficits that interfere with the protocol;
- Having severe spasticity (cannot handle Kinarm robot);
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP;
- Contraindications for robot-based therapy (e.g., uncontrolled epilepsy);
- Participation in another clinical investigation;
- Having any contraindications for fNIRS*：
- Uncontrolled head movements (e.g. tremor)
- Scalp lesion at optode sites (wound/incision/infection/hematoma)
- Decompressive craniectomy or large skull defect over target regions
- Persistent hair-optode coupling failure despite best practices, or non-removable obstructions preventing adequate coupling
- Having any contraindications for MRI**:
- Pacemaker
- Implantable Cardioverter Defibrillator (ICD)
- Cochlear implant
- Internal Insulin-pump
- Deep brain stimulation
- Any other metal device in the body
- Claustrophobia
- Having a history of a neuropsychiatric or neurologic disorder before the diagnosis of stroke (e.g., depression, traumatic brain injury)
- Use of psychoactive medication before the diagnosis of stroke (e.g., anti-depressive medication)
- Misuse (or history of misuse) of drugs/alcohol
- Currently undergoing a structured arm and/or hand training (e.g. engaging in playing a musical instrument)**.
- Stroke patients and healthy participants showing these exclusion criteria will be included in the RCT protocol, but will not be measured with fNIRS.
- Stroke patients showing these exclusion criteria will be included in the RCT protocol, but will not be measured with MRI. Healthy adults showing these exclusion criteria will not be included in the study.
Where it is running
- KU Leuven, Gebouw De Nayer — Leuven, Belgium
Full record on ClinicalTrials.gov
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